AzTrials
AzTrials

Diastasis RectiNapraDRAMNCT04652830

Naprapathy Training for Postpartum DRAM Prevention

A study testing Naprapathy training in people with Diastasis Recti, run by Karolinska Institutet at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A randomised controlled trial with the aim of analysing the effectiveness of a training program intended to prevent symptoms related to DRAM in the postpartum period. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Diastasis Recti
What is being tested?
Naprapathy training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteSweden
Study dates
1 Mar 2021to 31 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Uni- and multiparous women 3-12 months postpartum
  • Ability to understand Swedish language
  • Ability participate in a three months follow-up program
  • Diastasis of the rectus abdominis muscles > 3 cm

Who cannot join

  • Ongoing pregnancy
  • Age <18 years or >50 years
  • < 3 months or >12 months post partum
  • History of neurologic, musculoskeletal or psychiatric disorders
  • Interrectal diastasis < 3 cm

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Katarina Woxnerud, Naprapath contact

+46 702694900

katarina@woxnerud.se

Gabriel Sandblom, Ass Prof contact

+46 86162362

gabriel.sandblom@ki.se

Sweden1 site, 1 recruiting
  • Hela Kvinnans Klinik

    Stockholm, 116 37

    Katarina Woxnerud, Naprapath, +46702694900, info@helakvinnansklinik.se

    Recruiting

Other trials in Sweden

About this study

Official title: Randomised Controlled Trial to Assess the Benefit of Naprapathy Training for Preventing Problems from Rectus Abdominis Diastasis

A randomised controlled trial with the aim of analysing the effectiveness of a training program intended to prevent symptoms related to DRAM in the postpartum period.

Read the detailed description

Diastasis of the rectus abdominis muscles (DRAM) is a common condition after pregnancy and after great loss of weight. Distension of linea alba is a normal process during pregnancy caused by the growing fetus as well as from hormonal changes.

In the majority of cases, DRAM regresses during the postpartum period and the abdomen resumes its normal function. I some cases, however, the DRAM persists for a long period. This may result in trunk instability, back pain and decreased abdominal muscle strength. Risk factors for persisting DRAM are multiparity, high maternal age and cesarean delivery.

Little is known about how DRAM affects abdominal function. The lack of studies on the impact of DRAM on trunk instability and back pain has made it difficult to evaluate studies aiming at reducing the problems caused by DRAM.

Conservative management, including training aiming at strengthening the abdominal muscles, is usually considered the first hand alternative. There are, however, few studies on the effectiveness of training programs for the purpose of preventing DRAM.

The purpose of the present trial is to evaluate the effectiveness of a specific training program during a limited period of time postpartum in women with DRAM. The investigators also intend to study the changes in anatomy of linea alba during the postpartum period and explore whether the changes are affected by the training.

The study will be conducted as a randomized single-blind controlled trial. Women with diastasis of > 3 cm will be invited. The aim is to include 70 women. Half of them will be randomized to a training program for 3 month and the other half will be followed as a control group.

At the start of the study, the line alba is examined with ultrasound. The width of the diastasis is registered. The laxity and thickness of line alba are also evaluated. The abdominal circumference is measured at rest and under straining, in different postures.

At the start of the study, the woman is request to rate her level of physical activity (Baecke questionnaire) pain, self-assessed functional level (DRI), back pain (Oswestry low back disability index), urinary incontinence (UDI-6, IID-7) and quality of life (EQ-5D). The Abdominal Trunk Function Protocol (ATFP) is also registered at the start.

The assessors performing the ultrasound examination and physical examinations are blinded to the allocation. Women allocated to the training program perform exercises with a duration of ten minutes 6 days a week. They also perform 3 exercises with a duration of 60 seconds three times a day. The exercises are continued for three months. All women, those allocated to training as well as the control group, are invited to follow-up examinations 6 and 12 months after inclusion.

At both follow-up examinations the abdominal wall is investigated with ultrasound, the abdominal circumference is measured and the woman is requested to respond to all the questionnaires that she received at the start of the study.

Analyses will focus on the effect of the training program on the width and laxity of the linea alba as well as symptoms of back pain, trunk instability and incontinence.

Conditions
Diastasis Recti
Being tested
Naprapathy training, Control group
Keywords
Diastasis Recti, Naprapathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naprapathy trainingBehavioural

    Active training aimed at strengthening the abdominal muscles

  • Control groupOther

    No change of daily routines in regard to training

Study groups in NCT04652830
Study groupRoleWhat they receive
Naprapathy trainingActive comparatorTraining program for three months
Receives: Behavioral: Naprapathy training
Control groupPlacebo comparatorNo change of daily routines
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Abdominal Trunk Function

    Abdominal Trunk Function assessed with the Abdominal Trunk Function Protocol (ATFP). Six separate subscales.

    Measured: One year

Secondary outcomes (6)
  1. Disability

    Disability rated with the Disability Rating index (DRI). Rates ranging from 0 to 1200, where high ratings indicate worse outcome.

    Measured: One year

  2. Urinary Incontinence

    Urinary incontinence rated with UDI-6 (urinary distress inventory). Rates ranging from 0 to 18, where high rates indicate worse outcome.

    Measured: One year

  3. Health-related Quality of Life

    Quality of Life rated with EQ-5D

    Measured: One year

  4. Width of the diastasis

    Width measured with ultrasound

    Measured: One year

  5. Linea alba distortion index

    Distortion of the linea alba at rest and under tension assessed with ultrasound. Distortion index: average deviation of the LA from the shortest path between the recti, ranging from 0 to 1, higher index indicating greater distortion.

    Measured: One year

  6. Urinary incontinence

    Incontinence symptoms rated with the IID-7 (incontinence impact questionnaire). Rates ranging from 0 to 21, where high rates indicate worse outcome.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2020
  2. Study start1 Mar 2021
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blinded parallel randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04652830
Sponsor's protocol ID
NapraDRAM
Acronym
NapraDRAM
Status last verified
Jan 2025
First submitted
26 Nov 2020
Last updated
3 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Naprapathy training in people with Diastasis Recti, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katarina Woxnerud, Naprapath (+46 702694900, katarina@woxnerud.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abdominal Trunk Function (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in